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U.S. Department of Health and Human Services

Threshold of Regulation (TOR) Exemptions

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TOR No. 2010-002

Threshold of Regulation Exemptions are generally applicable and are effective for the food contact substance (FCS) for the listed intended use regardless of manufacturer or supplier.
Food Contact Substance: The food additives listed in: (a) Title 21 CFR Parts 174 through 186, (b) the inventory of effective food-contact substance notifications, and (c) the inventory of Threshold of Regulation exemptions issued under Title 21 CFR 170.39.
Use Limitations*: In the manufacture of food-contact articles that will be irradiated, incidental to the radiation processing of prepackaged foods. This exemption applies only when:
  1. The radiation processing is done in compliance with Title 21 CFR Part 179;
  2. The packaging materials are subjected to radiation doses not exceeding 4.5 kGy;
  3. The packaged food is irradiated either in a verifiably oxygen-free environment or while frozen and contained under vacuum.
Requestor: Sadex, Inc.
Quick Links to regulations in 21 CFR (referenced above):
170.39
179

*For references to food types and conditions of use, see Food Types & Conditions of Use for Food Contact Substances.

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